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Aug 4, 2020

PLACING OF NUTRITIONAL SUPPLEMENTS ON THE MARKET – new changes in the regime

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Our lawyer Tsvetelina Dimitrova and our jurisconsult Tsvetelina Mileva closely monitor the recent developments of the new registration regimes established with the new Food Act.

With the adoption of the new Food Act, in force from 09.06.2020 (Promulgated SG No. 52 of June 9, 2020, amended and supplemented SG No. 65 of July 21, 2020), the new changes in the regime for placing nutritional supplements on the market are applied.

The regulation used provided that producers or merchants, who are about to place nutritional supplements on the market in the Republic of Bulgaria for the first time should notify the Director of the respective Regional Directorate for Food Safety by submitting an explicit Notification.

The new regime provides for the placing on the market of nutritional supplements to be a subject of registration and to be initiated by submitting an explicit Application. According to the new requirements, the date of placing on the market of the nutritional supplements on the territory of the Republic of Bulgaria cannot be earlier than 14 days from the submission of the application.

By Order No. RD 11-1696 / 24.07.2020 of the Executive Director of the Bulgarian Food Safety Agency, the New Application for placing a nutritional supplement on the market and / or food intended for use after intensive muscular load was adopted.

Nutritional supplements are placed on the market on the territory of the Republic of Bulgaria after entry in a public national register of business operators, sites for production, processing and / or distribution of food and nutritional supplements, and foods intended for use after intense muscle load.

There are specifics regarding the administrative proceedings and the proceedings for issuing permits and certificates, which have started and have not been completed before the entry into force of the new Food Act, as well as the procedures for commissioning of food production and trade facilities, which are being processed according to the current regime.

According to the definition of “nutritional supplements” given in item 21 of § 1 of the Supplementary Provisions of the Food Act, the latter are “foods” and the new regime applies for all sites related to their production, processing and / distribution. In this regard, with the same Order No. RD 11-1696 / 24.07.2020 a New Application for registration / approval of a site for production, processing and / or distribution of food was adopted.

Attached to the Application are the documents specified in the form, as well as the relevant Annexes governing the distance trade of food, means of transport with which food is transported, and data on the mobile and temporary sites and food vending machines, are provided, depending on the method of organizing the applicant’s activity.

Nutritional Supplements_New Regime_Article_GTCo_EN

*This text does not constitute a legal advice and should not be taken into account in resolving legal disputes, but only to inform readers.

The team of Georgiev, Todorov & Co. Law Offices remains available for assistance and additional information related to the regime for placing nutritional supplements on the market and the implementation of the new Food Act.